Senior Global Clinical Operations Program Director
hace 5 meses
**Senior Global Clinical Operations Program Director**
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Join a dedicated Oncology team that’s growing fast and building a strong track record of success. We have multiple indications and many high-quality molecules at all stages of development - but we see even more potential. Oncology is driven by speed. We make bold moves at the cutting edge. Transforming molecules to change the practice of medicine. Here it’s our scale, agility and passion that makes sure we deliver fast, every time.
Late Development Oncology sits within our broader Oncology Research & Development organization. We take an inter-disciplinary approach including novel biomarkers, AI, novel endpoints and cutting-edge trial designs to shape the future of our business and Oncology. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next.
The Senior Global Clinical Operations Program Director - Late Oncology is a core global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals and Oncology), focusing on operational strategy and delivery. The span of the responsibilities is broad and may support one or several products depending on their size and complexity. The products supported will be Phase 3 development or on the Market, but the program may include studies in all phases of drug development.
**What you’ll do**:
The Senior Global Clinical Operations Program Director - Late Oncology sits within Clinical Operations of Late Stage Oncology R&D and is accountable for leading the Clinical Program Team (CPT), a strategic and operational leadership team. You will be responsible for program leadership of all Late Stage clinical development deliverables (scope, quality, budget, time, resource and risk). The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with AstraZeneca priorities and strategy. The DCD brings product knowledge and strategic thinking to support governance interactions, lead the delivery of a program of studies and co-ordinate the delivery of the clinical components of Health Authority submissions and documents. You will:
- Effectively partner with the Global Clinical Leader and Global Project Statistician to provide clear direction and aligned goals
- Drive and implement critical initiatives on the program level ensuring the CPT is operating as a high functioning team
- Deliver efficient and effective program management of all GPT clinical development deliverables including project strategy, design and delivery of program/studies to time, on budget and with quality
- Oversee clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports, and clinical contributions to inspection readiness.
- Lead all clinical operations activities within the program and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, Risk based Quality Management and external partner management)
- Act as the initial and program-level AZ operational interface with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
**Essential for the role**
- Bachelor of Science or equivalent degree.
- 12+ years progressive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
- 12+ years extensive experience across the product life cycle with experience in late stage development of Oncology assets.
- Comprehensive knowledge of clinical operations and the clinical and pharmaceutical drug development process (in the Oncology Therapeutic Area is preferred).
- Proven ability to develop programs to meet business goals and to assess business risk versus potential value.
- Significant experience of program management and use of project management techniques in complex project including resourcing, financial management and business case development.
- Willingness to travel both domestic and international.
**Desirable for the role**
- Master of Science / Advanced degree preferred
- Demonstrated ability to drive process improvement and/or functional work
- Experience of implementing changes in ways of working that focus on increasing efficiency
- Regulatory submission experience
- Previous success of working in Japan and China to ensure delivery of global programs to meet business needs
- Proven experience in leading teams through change
- Experience of and insight into th
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